Diabetic Peripheral Neuropathic Pain (DPNP)
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01314222
First received: February 11, 2011
Last updated: November 28, 2012
Last verified: November 2012
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Purpose
The purpose of the study is to evaluate the efficacy of study drug (BMS-954561) as compared to placebo in the treatment of patients with diabetic peripheral neuropathic pain (DPNP).
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetic Peripheral Neuropathic Pain |
Drug: BMS-954561 Drug: Pregabalin Drug: Placebo matching BMS-954561 Drug: Placebo matching Pregabalin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Multicenter, Double-blind, Placebo and Active-controlled, Cross-over Study of the Efficacy and Safety of BMS-954561 in Patients With Diabetic Peripheral Neuropathic Pain (DPNP) |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- The primary endpoint of this study is the average pain score for BMS-954561 vs. placebo. [ Time Frame: Up to 10 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Screening/Baseline Phase: Baseline ] [ Designated as safety issue: No ]
- Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Double-blind Treatment Phase: Week 1 ] [ Designated as safety issue: No ]
- Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Double-blind Treatment Phase: Week 2 ] [ Designated as safety issue: No ]
- Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Double-blind Treatment Phase: Week 3 ] [ Designated as safety issue: No ]
- Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Double-blind Treatment Phase: Week 4 ] [ Designated as safety issue: No ]
- Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Double-blind Treatment Phase: Week 5 ] [ Designated as safety issue: No ]
- Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Double-blind Treatment Phase: Week 6 ] [ Designated as safety issue: No ]
- Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Double-blind Treatment Phase: Week 7 ] [ Designated as safety issue: No ]
- Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Double-blind Treatment Phase: Week 8 ] [ Designated as safety issue: No ]
- Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Double-blind Treatment Phase: Week 9 ] [ Designated as safety issue: No ]
- Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Double-blind Treatment Phase: Week 10 ] [ Designated as safety issue: No ]
- Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Open-Label Phase: Week 2 ] [ Designated as safety issue: No ]
- Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Open-Label Phase: Week 4 ] [ Designated as safety issue: No ]
- Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Open-Label Phase: Week 8 ] [ Designated as safety issue: No ]
- Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Open-Label Phase: Week 12 ] [ Designated as safety issue: No ]
- Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Open-Label Phase: Week 16 ] [ Designated as safety issue: No ]
- Evaluate the effect of BMS-954561 compared to placebo using the Brief Pain Inventory-short form (BPI-SF). [ Time Frame: Open-Label Phase: Week 20 ] [ Designated as safety issue: No ]
- Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Double-blind Treatment Phase: Week 1 ] [ Designated as safety issue: No ]
- Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Double-blind Treatment Phase: Week 2 ] [ Designated as safety issue: No ]
- Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Double-blind Treatment Phase: Week 3 ] [ Designated as safety issue: No ]
- Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Double-blind Treatment Phase: Week 4 ] [ Designated as safety issue: No ]
- Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Double-blind Treatment Phase: Week 5 ] [ Designated as safety issue: No ]
- Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Double-blind Treatment Phase: Week 6 ] [ Designated as safety issue: No ]
- Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Double-blind Treatment Phase: Week 7 ] [ Designated as safety issue: No ]
- Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Double-blind Treatment Phase: Week 8 ] [ Designated as safety issue: No ]
- Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Double-blind Treatment Phase: Week 9 ] [ Designated as safety issue: No ]
- Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Double-blind Treatment Phase: Week 10 ] [ Designated as safety issue: No ]
- Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Open-Label Phase: Week 2 ] [ Designated as safety issue: No ]
- Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Open-Label Phase: Week 4 ] [ Designated as safety issue: No ]
- Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Open-Label Phase: Week 8 ] [ Designated as safety issue: No ]
- Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Open-Label Phase: Week 12 ] [ Designated as safety issue: No ]
- Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Open-Label Phase: Week 16 ] [ Designated as safety issue: No ]
- Evaluate the effect of BMS-954561 compared to placebo, on the Patient Global Impression of Change (PGIC) scale. [ Time Frame: Open-Label Phase: Week 20 ] [ Designated as safety issue: No ]
- Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [ Time Frame: Screening/Baseline Phase: Baseline ] [ Designated as safety issue: Yes ]
- Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [ Time Frame: Double-blind Treatment Phase: Week 1 ] [ Designated as safety issue: Yes ]
- Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [ Time Frame: Double-blind Treatment Phase: Week 2 ] [ Designated as safety issue: Yes ]
- Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [ Time Frame: Double-blind Treatment Phase: Week 3 ] [ Designated as safety issue: Yes ]
- Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [ Time Frame: Double-blind Treatment Phase: Week 4 ] [ Designated as safety issue: Yes ]
- Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [ Time Frame: Double-blind Treatment Phase: Week 5 ] [ Designated as safety issue: Yes ]
- Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [ Time Frame: Double-blind Treatment Phase: Week 6 ] [ Designated as safety issue: Yes ]
- Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [ Time Frame: Double-blind Treatment Phase: Week 7 ] [ Designated as safety issue: Yes ]
- Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [ Time Frame: Double-blind Treatment Phase: Week 8 ] [ Designated as safety issue: Yes ]
- Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [ Time Frame: Double-blind Treatment Phase: Week 9 ] [ Designated as safety issue: Yes ]
- Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [ Time Frame: Double-blind Treatment Phase: Week 10 ] [ Designated as safety issue: Yes ]
- Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [ Time Frame: Open-Label Phase: Week 2 ] [ Designated as safety issue: Yes ]
- Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [ Time Frame: Open-Label Phase: Week 4 ] [ Designated as safety issue: Yes ]
- Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [ Time Frame: Open-Label Phase: Week 8 ] [ Designated as safety issue: Yes ]
- Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [ Time Frame: Open-Label Phase: Week 12 ] [ Designated as safety issue: Yes ]
- Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [ Time Frame: Open-Label Phase: Week 16 ] [ Designated as safety issue: Yes ]
- Evaluate the tolerability and safety of BMS-954561 in patients with DPNP as measured by the frequency and severity of adverse events, frequency of severe adverse events, and discontinuations due to adverse events. [ Time Frame: Open-Label Phase: Week 20 ] [ Designated as safety issue: Yes ]
| Enrollment: | 178 |
| Study Start Date: | March 2011 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Arm 1: BMS-954561 40mg or 80mg
BMS-954561 40mg or 80mg TID to Placebo OR Placebo to 40mg or 80mg TID Active to Placebo or Placebo to Active (cross-over) |
Drug: BMS-954561
Capsule, Oral, 40mg or 80mg, Three times daily (TID), 10 weeks (double-blind) + 20 weeks (open-label BMS-954561)
Other Name: BMS-954561
Drug: Placebo matching BMS-954561
Capsule, Oral, 0mg, Three times daily (TID)
|
|
Arm 2: BMS-954561 150mg or 300mg
BMS-954561 150mg or 300mg TID to Placebo OR Placebo to 150mg or 300mg TID Active to Placebo or Placebo to Active (cross-over) |
Drug: BMS-954561
Capsule, Oral, 150mg or 300mg, Three times daily (TID), 10 weeks (double-blind) + 20 weeks (open-label BMS-954561)
Other Name: BMS-954561
Drug: Placebo matching BMS-954561
Capsule, Oral, 0mg, Three times daily (TID)
|
|
Arm 3: Pregabalin 100mg
Pregabalin 100mg TID to Placebo OR Placebo to 100mg TID Active to Placebo or Placebo to Active (cross-over) |
Drug: Pregabalin
Capsule, Oral, 100mg, Three times daily (TID), 10 weeks (double-blind) + 20 weeks (open-label BMS-954561)
Other Name: Lyrica in double-blind + BMS-954561 in open-label
Drug: Placebo matching Pregabalin
Capsule, Oral, 0mg, Three times daily (TID), 10 weeks (double-blind) + 20 weeks (open-label BMS-954561)
|
Detailed Description:
Allocation: Randomized Stratified; Intervention Model: Cross-over Versus Comparator + Placebo
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Type I or Type II diabetes with painful, distal, symmetrical, sensory-motor neuropathy attributed to diabetes, of at least 6 months duration.
- Score of ≥3 on Michigan Neuropathy Screening Instrument
- The patient is able to satisfactorily complete, in the Investigator's judgment, the Cognitive Battery.
- Based on patient diary information collected during the Screening/Baseline period, the patient has completed at least 5 of 7 daily diary entries and has an average weekly pain rating of at least 4 on the 11-point pain rating scale, in the week immediately prior to randomization (Baseline Visit).
- Male or female, 18-85 years of age.
Exclusion Criteria:
- History of complete lack of response to Pregabalin (at least 300 mg qd for 4 weeks) or Gabapentin (at least 1800 mg qd for 4 weeks).
- Other severe pain that may potentially confound pain assessment.
- Hemoglobin A1c > 9%
- Hemoglobin ≤ 9 g/dL
- Estimated glomerular filtration rate (eGFR) according to the re-expressed abbreviated (four-variable) Modification of Diet in Renal Disease (MDRD) Study equation ≤ 50ml/min/1.73m2
- Patients who have been on a stable dose of anticonvulsant, anticholinergic, diabetic meds, nicotine replacements, or any other smoking cessation meds for <4 weeks prior to randomization. Patients who are on stable doses for ≥ 4 weeks prior to randomization are allowed, however, there should be no adjustments to the dose of these medications during study.
- Patients currently on more than one drug for treatment of neuropathic pain (low dose opioids or antidepressants). Patients are allowed to participate if on a stable dose of for at least 4 weeks prior to randomization (Day1) and should remain stable during study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01314222
Locations
| United States, Alabama | |
| Achieve Clinical Research, Llc | |
| Birmingham, Alabama, United States, 35216 | |
| United States, Arizona | |
| Arizona Research Center | |
| Phoenix, Arizona, United States, 85023 | |
| United States, California | |
| Torrance Clinical Research | |
| Lomita, California, United States, 90717 | |
| Office Of Richard S. Cherlin, Md | |
| Los Gatos, California, United States, 95032 | |
| Diablo Clinical Research, Inc. | |
| Walnut Creek, California, United States, 94598 | |
| United States, Florida | |
| Brain Matters Research | |
| Delray Beach, Florida, United States, 33445 | |
| Renstar Medical Research | |
| Ocala, Florida, United States, 34471 | |
| Compass Research, Llc | |
| Orlando, Florida, United States, 32806 | |
| Comprehensive Clinical Development, Inc. | |
| St Petersburg, Florida, United States, 33716 | |
| United States, Illinois | |
| Northwest Neurology Ltd. | |
| Lake Barrington, Illinois, United States, 60010 | |
| United States, Kentucky | |
| Commonwealth Biomedical Research, Llc | |
| Madisonville, Kentucky, United States, 42431 | |
| United States, Missouri | |
| The Center For Pharmaceutical Research. Pc | |
| Kansas City, Missouri, United States, 64114 | |
| Mercy Health Research | |
| St. Louis, Missouri, United States, 63141 | |
| United States, New York | |
| Finger Lakes Clinical Research | |
| Rochester, New York, United States, 14618 | |
| United States, North Carolina | |
| Physicians East P.A. | |
| Greenville, North Carolina, United States, 27834 | |
| Pmg Research Of Winston-Salem | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, Ohio | |
| Radiant Research, Inc. | |
| Akron, Ohio, United States, 44311 | |
| Neurology & Neuroscience Center Of Ohio | |
| Toledo, Ohio, United States, 43623 | |
| United States, Tennessee | |
| Clinical Research Associates, Inc. | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Dallas Diabetes & Endocrine Center | |
| Dallas, Texas, United States, 75230 | |
| R/D Clinical Research, Inc. | |
| Lake Jackson, Texas, United States, 77566 | |
| France | |
| Local Institution | |
| Dijon Cedex, France, 21079 | |
| Local Institution | |
| Nantes Cedex 1, France, 44093 | |
| Local Institution | |
| Nice Cedex 1, France, 06003 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
No publications provided
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01314222 History of Changes |
| Other Study ID Numbers: | CN169-001, 2010-023042-70 |
| Study First Received: | February 11, 2011 |
| Last Updated: | November 28, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices |
Additional relevant MeSH terms:
|
Neuralgia Diabetic Neuropathies Pain Neurologic Manifestations Nervous System Diseases Peripheral Nervous System Diseases Neuromuscular Diseases Signs and Symptoms Diabetes Complications Diabetes Mellitus |
Endocrine System Diseases Pregabalin Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Anticonvulsants |
ClinicalTrials.gov processed this record on May 19, 2013